T-Control® Safety for Cytostatics Management
- Conditions
- Non-muscle-invasive Bladder Cancer
- Registration Number
- NCT06678633
- Lead Sponsor
- Rethink Medical SL
- Brief Summary
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability and workload of T-Control®. The main questions it aims to answer are:
* Does T-Control® lower the rate of spillages occurred during intravesical treatments?
* Is T-Control® a better device in terms of usability during intravesical treatments?
* Does T-Control reduce the workload perceived by healthcare professionals during intravesical treatment?
Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages.
Participants will:
* Undergo intravesical therapy with one of the 2 devices used in the study: T-Control® catheter (intervention arm) or Folysil® silicone catheter (control arm).
* At the end of the procedure (1-2 hours), the catheter will be removed or changed.
* Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation.
- Detailed Description
This is a comparative, randomised and prospective pilot tudy with two arms that aims to compare the T-Control® catheter versus a conventional Foley-type catheter (Folysil®, Colopalst) in bladder cancer patients who require intravesical chemotherapy or immunotherapy treatment, monitoring the patient from the insertion of the catheter until its removal or change (1 to 2 hours).
The general purpose of this pilot study is to determine the feasibility of a clinical study analysing the advantages that T-Control® can provide, compared with usual clinical practice in the participating center, with respect to chemotherapy and immunotherapy administration and waste management in a prospective, randomised, comparative pilot study, in patients with bladder cancer who need intravesical therapy. This will allow to optimise the design, assess whether recruitment and interventions are sufficient to allow the trial to progress, and gather preliminary data with the following objectives:
* To determine the safety of T-Control® versus the usual clinical practice in the participating center, by comparing the rate of accidental spillages due to the catheter in patients that require oncological intravesical treatments.
* To determine and compare the usability of T-Control® versus the usual clinical practice in the participating center.
* To measure and compare the level of workload perceived by healthcare professionals with both types of urinary catheters.
All those patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy will be invited to participate and will be interviewed in an initial visit, where the inclusion and exclusion criteria will be checked.
After the end of each treatment the health professionals who have participated, and after giving their informed consent, will be asked to record all the spillages and leakages occurred during the therapy, as well as to measure the usability and the workload perceived with the type of catheter used.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- Men or women aged ≥18 years.
- Patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy.
- Patients requiring recurrent intravesical instillations for their treatment.
- Signed consent agreement.
- Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
- Inability to read and understand Portuguese or english.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of accidental spillages Intravesical therapy procedure (1-2 hours) The number of spillages with cytostatics, body fluids or other non-hazardous spillages divided by the number of interventions (intravesical therapy procedures)
- Secondary Outcome Measures
Name Time Method Device-usability Intravesical therapy procedure (1-2 hours) The degree of usability perceived by the health professionals involved in the intravesical procedure will be evaluated through an ad hoc questionnaire
Workload Intravesical therapy procedure (1-2 hours) The workload perceivef by healthcare professionals involved in each intravesical therapy procedure will be evaluated through the NASA-TLX questionnaire. This is a subjective, multidimensional and widely used evaluation tool that qualifies the perceived workload to evaluate the effectiveness of a task, system or equipment or other performance aspects. The questionnaire evaluates six dimensions (mental, physical and temporal demand, performance, effort and frustration) which enables rating them on a 1 to 10 scale, 1 being the lowest score and 10 the highest score.